Clinical Trials Logo

Clinical Trial Summary

This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.


Clinical Trial Description

This study has the goal of understanding the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults. To implement this, the investigators will conduct a pilot randomized clinical trial in which fifty older adults (with amnestic mild cognitive impairment and sleep disturbance) will be assigned to different treatment groups to test the effects of cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE) over the course of 6 months. CBTI is a psychotherapy intervention designed to address maladaptive cognitive and behavioral patterns associated with sleep and bedtime. SWAE is administered through a non-invasive headband that detects and amplifies endogenous slow-wave activity using playing acoustic stimulation ("pink noise"). Group differences will be compared on the changes in cognitive performance and plasma biomarkers of Alzheimer's disease (phosphorylated tau). The investigators will also explore potential mechanisms behind the relationship between sleep and cognition/biomarkers by investigating a range of objectively measured sleep metrics (e.g., sleep architecture, sleep duration, arousals) along with APOE genotype and depressive symptoms. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05987007
Study type Interventional
Source New York State Psychiatric Institute
Contact Hyun Kim, PhD
Phone 646-774-8459
Email HK3141@cumc.columbia.edu
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT04959214 - The Effect Of Progressıve Relaxatıon Exercıses N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Completed NCT05555186 - The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being N/A
Completed NCT05093465 - A Comparison of Two Behavioral Sleep Interventions Among College Students (ProjectTECH) N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Completed NCT04566822 - Calm Sleep Coaching N/A
Not yet recruiting NCT06406309 - Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD N/A
Recruiting NCT00860756 - Sleep Disturbance in Deployed Soldiers Phase 0
Recruiting NCT05699837 - Alpha Entrainment for Pain and Sleep (Extension) N/A
Completed NCT06108115 - Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder N/A
Completed NCT05511818 - Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Not yet recruiting NCT06104280 - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment N/A
Enrolling by invitation NCT04290650 - Sleep Disturbances in Patients With Psychotic Symptoms (AkuSleep) N/A
Recruiting NCT04207502 - Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
Suspended NCT03908905 - Sleep Disturbances and Chronic Widespread Pain
Completed NCT03269760 - Multimodal Sleep Pathway for Shoulder Arthroplasty Phase 1
Completed NCT04990206 - Improving Sleep Health in Adults With Overweight or Obesity N/A
Completed NCT03112824 - Functional Assessment of Ashwagandaha Root Extract During Weight Loss N/A